FDA Medical Device Recalls (openFDA)
Lifescan Inc: LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter
- Recall number
- Z-0272-06
- Recalling firm
- Lifescan Inc
- Product
- LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter
- Status
- Terminated
- Initiated
- 2005-10-10
- Posted
- 2005-12-08
- Terminated
- 2006-11-21
- Reason
- Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
- Root cause
- Other
- Action
- A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit.
- Quantity
- 2843 kits
- Distribution
- Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution
- Lot, serial or model codes
- Listing Number B026094, Code 90273 Kaban, all demo kits shipped between 04/08/2005 and 08/23/2005
- 510(k) numbers
- ["K043197"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 2939301
- Firm city
- Milpitas
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28